{"entity":{"id":"idea-tr2-cdx-mutual-recognition","kind":"idea","name":"Regulators recognise each other's companion diagnostic approvals","aka":[],"tldr":"A test approved to select patients for a drug in the US must go through separate approval in Europe, Japan and elsewhere, delaying the drug. Accepting each other's test approvals would fix the delay.","summary":"Companion diagnostics are regulated separately from drugs and differently by region (FDA premarket approval, EU IVDR, PMDA). Divergence delays drug access and multiplies bridging studies. A mutual-recognition agreement for companion diagnostics among ICH-aligned regulators, analogous to Project Orbis for drugs, with a shared analytical validation dossier and a single bridging-study standard, would remove months to years of delay.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Biomarkers are not validated or standardised): Fernandez et al., Examination of low ERBB2 protein expression in breast cancer tissue (JAMA Oncology 2022)","url":"https://doi.org/10.1001/jamaoncol.2021.7239"}],"tags":[],"related":["foundation-medicine","foundationone-cdx"],"cancers":[],"sections":[],"technologies":["companion-diagnostic"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":["b-biomarker-validation","b-regulatory-fragmentation"],"keyPapers":["paper-fernandez-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Mutual recognition reduces the median lag between drug approval and companion diagnostic availability in the second region from over a year to under three months.","rationale":"Project Orbis and the Access Consortium show that regulators can share reviews; analytical validation of a test is less region-dependent than clinical practice.","test":"Pilot recognition of five companion diagnostics between two regulators and measure time to availability against contemporaneous non-pilot tests.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-tr2-cdx-mutual-recognition/","neighbours":{"company":[{"id":"foundation-medicine","kind":"company","name":"Foundation Medicine (Roche)","route":"/companies/foundation-medicine/"}],"drug":[{"id":"foundationone-cdx","kind":"drug","name":"FoundationOne CDx / Liquid CDx","route":"/drugs/foundationone-cdx/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}],"paper":[{"id":"paper-fernandez-jama-oncol","kind":"paper","name":"Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue","route":"/key-papers/paper-fernandez-jama-oncol/"}]}}